Kornimate/medical-research-clean huggingface dataset:
a study to assess efficacy and safety of glpg1972/s201086 in participants with knee osteoarthritis

Conditions: Osteoarthritis

Summary: this study is a phase 2, 52-week international, multi-regional, multi-center, randomized, double-blind, placebo-controlled dose-ranging study for the treatment of osteoarthritis.


Eligibility criteria:
inclusion criteria: * male participants or female participants of non-childbearing potential and not breastfeeding. * body weight \> 40 kg, body mass index (bmi) \< 40 kg/m\^2. * diagnosed for knee osteoarthritis based on clinical and radiological criteria of the american college of rheumatology. * history of knee pain for at least 6 months and on the majority of days (\> 50%) during the preceding month. * symptom severity defined by a pain ≥ 40 mm and ≤ 90 mm on visual analogue scale (vas, 100 mm) at screening and inclusion visits. * documented need for symptomatic as needed-treatment for osteoarthritis (oa) in the target knee with systemic non-steroidal anti-inflammatory drugs (nsaids) and/or other analgesics exclusion criteria: * severe clinical knee malalignment according to the investigator. * knee prosthesis already implanted (\< 1 year) or not well-tolerated (contralateral side). * knee prosthesis already foreseen within the study period (whichever side). * hip prosthesis recently implanted (\< 1 year) or foreseen within the study period (whichever side). * previous osteotomy on the inferior limbs (whichever side). * surgical operation on the target knee within the 12 months prior to the screening visit or planned during the study. * diagnostic arthroscopy of the target knee within the 6 months prior to the screening visit or planned during the study. * other pathologies affecting the target knee. * any contraindication to magnetic resonance imaging (mri) including the inability to undergo a knee mri exam because of inability to fit in the scanner or knee coil.
a study to investigate tanezumab in patients with interstitial cystitis/ painful bladder syndrome

Conditions: Cystitis, Interstitial

Summary: in a previous study in patients with interstitial cystitis/ painful bladder syndrome (ic/pbs), tanezumab has shown to be efficacious in relieving the pain associated with ic/pbs, as well as some effect on reducing urinary urgency. only one dose was studied, and tanezumab was well tolerated. in this study, the hypothesis being tested is that tanezumab will show efficacy at several doses on reducing pain with sufficient tolerability. tanezumab's safety will also be assessed at different dose levels

this study was terminated on 16 november 2010 following a us fda partial clinical hold for the tanezumab interstitial cystitis clinical study announced on 19 july 2010 for potential safety issues, and following a pre-planned interim analysis.

Eligibility criteria:
inclusion criteria: * patients with interstitial cystitis/ painful bladder syndrome for more than 6 months with moderate to severe pain and a micturition frequency greater than 7 per day. * patients who have been on stable oral medicines for interstitial cystitis/ painful bladder syndrome for at least 3 months. other therapies might need to be stopped. exclusion criteria: * patients on certain recent treatments for interstitial cystitis/ painful bladder syndrome. * body mass index (bmi) of \>39 kg/m2. * history of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or igg-fusion protein. * patients with peripheral neuropathy. * patients with type i or type ii diabetes mellitus who have an hba1c \> 8.0%.

Keywords: randomized double blind placebo-controlled parallel-group dose-range finding interstitial cystitis efficacy pain urinary symptoms safety
postoperative pain after the use of different root canal sealers

Conditions: Postoperative Pain

Summary: this study evaluated the postoperative pain after the endodontic treatment using ah plus, endoseal mta and endosequence bc sealers in root canal obturation.


Eligibility criteria:
inclusion criteria: * participants between 18 - 60 years of age, * good oral hygiene, * have not taken any analgesics in the last day, * have not taken antibiotics in the last week, * patients diagnosed with asymptomatic irreversible pulpitis caused by deep carious lesion on the mandibular first or second molar teeth. * a prolonged positive response to cold vitality tests, * the presence of pulp, which is exposed during caries removing and bleeding with a dense and thick consistency. * the periapical region was healthy in radiographic diagnosis. exclusion criteria: * devital teeth that have no response to pulp test, * the presence of advanced periodontal disease, * having a systemic disease that requires antibiotic prophylaxis, * radiographically more than 30° root inclination, presence of clear apex, presence of calcification, presence of root resorption, * the need for root canal treatment which is mesial and/or distal neighbour of the tooth to be treated, * the presence of a sinus tract in the relevant tooth region, * having systemic diseases that reduce immune system resistance, * participants with allergic sensitivity to materials and agents that should be used during the root canal treatment, * allergic sensitivity to local anesthetics, * pregnant participants or participants in the lactation period, * over preparation or over filling during treatment, * teeth which cannot be applied a rubber-dam, * teeth which was damaged enough to require coronal fiber post application, * sensitive to ibuprofen based analgesics.

Keywords: postoperative pain endoseal mta endosequence bc ah plus root canal filling endodontic treatment
the effects of nateglinide and acarbose on the post-prandial glucose control in type 2 diabetic patients

Conditions: Diabetes Mellitus; Type 2 Diabetes Mellitus

Summary: in type 2 diabetic patients, tight blood glucose control often requires both fasting and post-prandial glucose control separately. in the diabetic patients already on the insulin glargine treatment for the control of fasting blood glucose, additional measures for the control of post-prandial glucose level are often required. nateglinide and acarbose are frequently used for this purpose. we hypothesized that the short acting sulfonylurea "nateglinide" may be more efficacious in diabetic patients with appreciable endogenous insulin secretion, while acarbose may be more efficacious in patients with lower endogenous insulin secretion. and we also want to clarify the clinical and biochemical parameters that can predict the responsiveness to each agent in this multi-center randomized open cross-over clinical study.


Eligibility criteria:
inclusion criteria: * korean * type 2 diabetes mellitus * no prior history of diabetic ketoacidosis * hba1c between 7.5-10.0% exclusion criteria: * type 1 diabetes mellitus * gestational diabetes mellitus * secondary diabetes mellitus * severe hyperglycemia with symptoms * severe chronic diabetic complications (pdr,s-cr\>1.3mg/dl)
investigation of the drug dimethoxbenzylidene anabaseine in treating schizophrenia patients

Conditions: Schizophrenia; Psychotic Disorders

Summary: this study will determine the effectiveness of a drug, dimethoxbenzylidene anabaseine, in producing beneficial effects similar to that of nicotine in individuals with schizophrenia.

schizophrenia is a chronic and severe brain disorder that can significantly impact quality of life. it is characterized by delusions, paranoia, and disordered thinking. the cause of schizophrenia has not yet been determined. however, there are many treatments, including drug therapy and cognitive behavioral therapy, that may help to alleviate symptoms of the condition. nicotinic receptors are involved in a number of biological processes; they are numerous throughout the central and peripheral nervous systems and are diverse in structure and expression. genetic and neurobiological research has identified decreased expression of the a7 nicotinic receptor as an element in schizophrenia that is related to poor psychosocial outcome. data indicate that drug therapy may reduce this deficit in receptor expression. nicotine has been found to stimulate the a7 nicotinic receptor; however, the physiological dependence associated with nicotine makes it an undesirable option. dimethoxbenzylidene anabaseine (dmxb-a) can stimulate the a7 nicotinic receptor; its advantages include easy oral administration and the lack of dependence-causing effects. this study will determine whether dmxb-a can safely and effectively stimulate the a7 nicotinic receptor in schizophrenia patients and reduce their neurobiological symptoms. this study will last 6 weeks. participants will have study visits each week for the duration of the study. during each visit, participants will be randomly assigned to receive either dmxb-a or placebo. an electrocardiogram (ekg) will measure the heart function of participants and participants' blood pressure will be measured. after the first dose of either dmxb-a or placebo, participants will receive a second dose 2 hours later. an evoked potential test, which measures the brain's response to stimuli, will be performed after both doses. neuropsychological tests, such as verbal reasoning and visual retention, will be performed following the second dose of either dmxb-a or placebo.

Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia exclusion criteria: * history of cardiovascular illness or neurological illness other than schizophrenia * current substance abuse, including nicotine * history of clozapine use

Keywords: evoked potentials 3-(2,4-dimethoxybenzylidene)anabaseine dmxb-a receptors, nicotinic
an analysis of the improvement and quality of life trends for uk/roi patients treated with cosentyx (secukinumab) in a retrospective analysis of the badbir data source

Conditions: Plaque Psoriasis

Summary: this was a retrospective, observational study of psoriasis patients treated with secukinumab, using secondary data from badbir. badbir is a uk/roi pharmacovigilance registry that was initiated in 2007 to monitor the long-term safety of biologic drugs used to treat psoriasis. the study used longitudinal data within the registry to track the trends relating to the disease. for the analysis of improvement and patient reported qol, patients with a minimum of one follow-up visit were included. the index date was defined as the date of initiation of secukinumab treatment, and follow-up visits were at 6-, 12-, 18-, \& 24-months post-index.

the badbir data was current up until the 31st august 2019 for this analysis. study period: from 1st july 2015, as secukinumab was included in badbir in january 2016 and patients backdated 6 months, to 31st august 2019. identification period: from 1st july 2015 to 31st august 2019 was used to identify applicable patients for analysis. index date: initiation of secukinumab treatment within the badbir database.

Eligibility criteria:
inclusion criteria: inclusion criteria for the biologic cohort: * age ≥18 years at initiation of secukinumab. * at least one follow-up visit post-registry enrollment. * on-label dosing of secukinumab of 300mg. inclusion criteria for the psa biologic cohort: * age ≥18 years at initiation of secukinumab. * at least one follow-up visit post-registry enrollment. * on-label dosing of secukinumab of 300mg. * diagnosis of psa at baseline. exclusion criteria: - the patient did not meet the criteria stated above.

Keywords: cosentyx, secukinumab, quality of life, uk
the effect of proton pump inhibitor and polaprezinc combination therapy for healing of endoscopic submucosal dissection-induced ulcer

Conditions: Gastric Adenoma; Early Gastric Cancer

Summary: endoscopic submucosal dissection (esd) is an advanced technique that enables en bloc resection of superficial tumors in the gastrointestinal tract. esd, however, is a time-consuming procedure that requires a high level of endoscopic skill to achieve a desirable oncologic outcome. several procedure-related complications may occur after esd. especially, iatrogenic ulcer bleeding after esd can be a concern for both endoscopists and patients. in order to reduce the bleeding rate, proton pump inhibitors (ppis) are administered after esd. in addition, ulcer protective agents such as rebamipide can be added to ppis for accelerating ulcer healing. we aimed to evaluate the efficacy of polaprezinc for healing of iatrogenic ulcer.


Eligibility criteria:
inclusion criteria: 1. age, between 19 and 79 2. patients with gastric adenoma or early gastric cancer 3. patients with ecog-ps 0 or 1 4. patients with adequate renal function 5. patients with adequate hepatic function 6. patients with adequate bone marrow function exclusion criteria: 1. patients who has taken the medications for ulcer including ppis, h2 blockers, and mucosal protective agents within 3 months prior to the esd. 2. patients who has taken steroid or nsaidswithin 3 months prior to the esd. 3. patients who has undergone gastrostomy 4. patients with allergy for pantoprazole, polaprezinc, or rebamipide. 5. pregnant or breast feeding.
rollover study of bms-354825 in patients with cml and ph+all

Conditions: Chronic Myelogenous Leukemia; Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

Summary: to assess the safety of dasatinib (bms-354825) in subjects with imatinib resistant or intolerant chronic myelogenous leukemia (cml) and philadelphia chromosome positive (ph+) acute lymphoblastic leukemia (all) who are resistant or intolerant to treatment and will continue study drug after completing the previous phase i/ii study (ca180031/nct00337454)


Eligibility criteria:
inclusion criteria: * subjects who were eligible and completed the previous phase i and ii study (ca180031/nct00337454) and for whom the principal investigator has deemed that continuation of study drug is in the best interest of the subject exclusion criteria: * women who are pregnant or breastfeeding * subjects who are eligible and willing to undergo transplantation at pre-study * non-hematologic intolerance to dasatinib (bms-354825) in the previous phase i and ii study (ca180031/nct00337454)
maternal well-being in the postnatal stage

Conditions: Postpartum Depression; Postpartum Disorder

Summary: the objective of this study is to design and validate an online intervention aimed at promoting well-being in women with postpartum depression. for this, the design of a multicomponent protocol consisting of empirically validated positive interventions and comparing these with a group cognitive behavioral therapy (cbt) is proposed, following the national institute for health and care excellence (nice) recommendations for the treatment of depression. participants will be screened for inclusion in the program if they meet clinical criteria. after that, they will be randomly assigned to a cbt group or a positive psychology intervention (ppi) group.

participants will be randomly assigned to the cbt group or the ppi group. both groups will be treated identically except for the type of intervention. group assignment will be blind to both patients and investigators. both interventions have 10 weekly sessions. sessions will be in groups and online. cbt includes 3 modules: behavioral activation, cognitive restructuring, and interpersonal skills. main contents (10 sessions): (1) symptoms of depression. myths about motherhood. cbt approach; (2) stress and anxiety. relaxation; (3 and 4) increase pleasurable activities. balance in life. to manage time; (5) management of negative thoughts. health concerns; (5 and 6) increase positive thoughts; (7) social skills; (8) communication skills and parner support; (9) plan for the future. new routines and strategies; (10) relapse prevention. cbt has been shown to be effective in reducing depressive symptoms and modifying attentional biases (pearson et al., 2013). on the other hand, a new protocol of positive interventions adapted for women after maternity (ppi) will be designed and applied. this multicomponent protocol includes interventions that have already been empirically validated in treating depression. ppi includes 2 modules: hedonic well-being and eudaimonic well-being. main contents (10 sessions): (1) symptoms of depression. myths about motherhood. ppi approach; (2) mindfulness and positive emotions; (3) gratitude and savoring; (4) emotion regulation (5) positive relationships and social support; (6) compassion; (7) personal strengths; (8) goals and values; (9) resilience; (10) relapse prevention.

Eligibility criteria:
inclusion criteria: * women who have been mothers in the last year exclusion criteria: * women who have been mothers in the last month, * women who meet the diagnostic and statistical manual of mental disorders (dsm-5) criteria for substance abuse and/or dependence within 30 days prior to study participation, * women who have a serious mental disorder that makes it difficult to follow the protocol (e.g. serious neurocognitive problems or brain damage; schizophrenia and other psychotic disorders).
procalcitonin guided versus conventional antibiotic therapy in patients with sepsis in the icu

Conditions: Sepsis; Intensive Care

Summary: the adequacy of early empiric antimicrobial therapy is an important factor in determining the outcome in patients with severe sepsis. the duration of adequate antibiotic therapy in these patients however is less clear. duration of antibiotic therapy in patients with sepsis in the icu based on inflammatory markers has not been extensively studied. procalcitonin (pct) is an acute phase protein that has prognostic value in critically ill patients and can be used to monitor disease activity in sepsis and systemic inflammation. this study will examine the effect of pct guided antibiotic therapy compared with conventional antibiotic therapy on treatment duration in patients with sepsis admitted to the icu.


Eligibility criteria:
inclusion criteria: * patients admitted to the icu * age \> 18 years * antibiotic therapy for sepsis with a suspected or proven focus of infection exclusion criteria: * age \< 18 years * pregnancy * infection or presumed infection requiring prolonged antibiotic therapy (osteomyelitis, meningitis, endocarditis, septic arthritis, mediastinitis, tuberculosis, pneumocystis jiroveci pneumonia, toxoplasmosis, legionellosis, listeriosis) * indication for prolonged systemic prophylactic antibiotic therapy * severe viral or parasitic infections (hemorrhagic fever, malaria) * antibiotic therapy started 48 hours before enrollment * severe immunocompromised patients (aids with a cd4 count \< 200cells/mm3, severe neutropenia(\<500 neutrophils/mm3), patients undergoing immunosuppressive therapy after solid organ transplantation) * patients foregoing life sustaining treatment

Keywords: biomarkers antibiotic therapy
metabolic and hemodynamic reserve in pediatric sca

Conditions: Child, Only; Brain Diseases; Sickle Cell Disease; Anemia, Sickle Cell

Summary: the purpose of this research study is to better understand how blood flow and metabolism change can influence brain development in the early decades of life. sca participants and healthy controls are age and sex-matched for comparison. within the sca cohort, children with infarcts may have thinner cortices than those without, reflecting a greater loss. the investigators will examine brain blood flow and metabolism using magnetic resonance imaging (mri). the brain's blood vessels expand and constrict to regulate blood flow based on the brain's needs. the amount of expanding and contracting the blood vessels may vary by age. the brain's blood flow changes in small ways during everyday activities, such exercise, deep concentration, or normal brain growth. significant illness or psychological stress may increase the brain's metabolic demand or cause other bigger changes in blood flow. if blood vessels are not able to expand to give more blood flow when metabolic demand is high, the brain may not get all of the oxygen it needs. in extreme circumstances, if the brain is unable to get enough oxygen for a long time, a stroke may occur. sometimes small strokes occur without other noticeable changes and are only detectable on an mri. these are sometimes called "silent strokes." in less extreme circumstances, not having a full oxygen supply may cause the brain to grow and develop more slowly than when it has a full supply. one way to test the ability of blood vessels to expand is by measuring blood flow while breathing in carbon dioxide. carbon dioxide causes blood vessels in the brain to dilate without increasing brain metabolism. during this study participants may be asked to undergo a blood draw, mri, cognitive assessments, and brief questionnaires. the study team will use a special mask to control the amount of carbon dioxide the participants breathe in.


Eligibility criteria:
healthy controls: * healthy controls ages 4-21 years of age * able to participate in mri scan without sedation * not currently pregnant * no significant psychiatric history, defined as having a severe psychiatric diagnosis, per pi discretion * no history of epilepsy * no history of stroke or cerebrovascular disease * may have occasional headaches if not taking a daily preventative medication for headaches * not on vasodilatory medication, such as sildenafil or verapamil sickle cell anemia participants: * ages 4-21 years of age * hb ss or sbeta-thal * able to participate in mri scan without sedation * not currently pregnant * not on vasodilatory medication, such as sildenafil or verapamil * no known vasculopathy

Keywords: sickle cell anemia cerebrovascular reactivity cerebral oxygen metabolism cortical thickness gray matter carbon dioxide magnetic resonance imaging brain development
usability and acceptability study of the p-step mobile application

Conditions: Asthma; Chronic Obstructive Pulmonary Disease; Interstitial Lung Disease; Coronary Heart Disease; Heart Failure; Type 2 Diabetes

Summary: assess the usability and acceptance of the p-step app, through allowing participants with specific chronic conditions to pilot the app for 12-weeks.

participants are asked to use mobile app for 12 weeks \& complete baseline, 6 week and 12 week assessments.

Eligibility criteria:
inclusion criteria: * adult ≥ 18 years * live within the boundaries of the test site (leicester, uk). * diagnosed with one (or more) of the following conditions: asthma, chronic obstructive pulmonary disease (copd), interstitial lung disease (ild), coronary heart disease (chd), heart failure (hf), type 2 diabetes * android smartphone which has access to the internet * can walk outside for a minimum of 5 minutes without feeling uneasy/unsteady * available to pilot the app for 12 weeks from august-december 2023 * able to give informed consent to participate in the evaluation exclusion criteria: * english language restriction * advised not to do exercise by a health care professional, in the last 12 months. * access to an ios smartphone only * diagnosed with dementia, learning disability, mental health disorders (other than depression or anxiety), epilepsy * receiving palliative care * pregnant * chest pain at rest * unsteady when standing or walking * current cancer patient * part of the p-step user engagement group

Keywords: exercise pollution air quality